A Letter to Our Partners
During the last decades, significant gaps were recognized in the development of innovative drugs and devices for children. This insight resulted in regulations requiring clinical trials of new drugs in pediatric populations, including newborns. With this mandate, it is now incumbent on all of us to ensure a sense of urgency to deliver high-quality data from trials designed to improve child health and maximize impact.
The Institute for Advanced Clinical Trials for Children (I-ACT for Children) was established as an independent 501(c)3 non-profit with the goal of working with public and private stakeholders to catalyze improvements in the quality and timely completion of global pediatric studies, which will address the gap in evidence for best use of therapeutics in children. We believe that children of all ages deserve innovative medical therapies that are developed with the same level of urgency, quality and commitment afforded adults.
The Institute represents an extension of the work of the Pediatric Clinical Trials Stakeholders Forum sponsored by the American Academy of Pediatrics in late 2014 (Bogue et at. Pediatric Research (2016) 79, 662–669 doi:10.1038/pr.2015.255), and is founded on recommendations made by the Pediatric Clinical Trials Consortium of Critical Path Institute in its 2016 Advisory Report. We are grateful to all of those who have worked to establish and support I-ACT for Children and invite like-minded individuals and institutions to join us in this effort by becoming a member as we anticipate formal launch of the Institute’s work in 2017.
The Board of Directors Institute for Advanced Clinical Trials for Children
Membership benefits vary depending on the type of member and availability, but those benefits may include:
- Participation in neutral, independent forums in which parents, patients, regulators, academia and industry sponsors advance knowledge of children’s health and wellness and action plan to solve important challenges
- Educational forums in which to learn about special considerations in good clinical practices in pediatric clinical trials and innovative study design methods
- Engagement with a trial-ready pediatric clinical trials network, supported by pooled infrastructure funding to enable efficient planning and conduct of pediatric clinical trials
- Awareness of evolving regulatory guidance, tools, standards, and methods specific to pediatrics
- Access to standard templates for agreements, budgeting, ethics processes and shared standards in trials management to ensure consistency of quality
- Best practices forums for investigators, nurses, coordinators, sponsors and others to accelerate development of innovative medicines and devices for children globally